EksoNR
FDA 510(k) clearance K200574 · decided 2020-06-19
Clearance details
- K-number
- K200574
- Device name
- EksoNR
- Applicant
- Ekso Bionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-05
- Decision date
- 2020-06-19
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- PHL
- Device class
- 2
- Regulation number
- 890.3480
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Richmond, CA, US
- Third-party review
- No
- Expedited review
- No
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| Atalante (K221859) | Wandercraft SAS | 2022-12-29 |
| EksoNR (K220988) | Ekso Bionics, Inc. | 2022-06-09 |
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Recalls involving this device
No recalls on record reference this clearance.